Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055

AstraZeneca19 enrolled

Overview

The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Solid Tumors Advanced Solid Malignancies

Interventions

AZD8055DRUG

Tablets, orally administered, twice daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective * Relatively good overall health other than cancer Exclusion Criteria: * Poor bone marrow function (not producing enough blood cells) * Poor liver or kidney function * Serious concomitant illness

Locations (1)

Research Site

Tokyo, Japan

Outcomes

Primary Outcomes

Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)

Time frame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.

Secondary Outcomes

To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours

Time frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1

To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)

Time frame: Every cycle

Data from ClinicalTrials.gov

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